Joyce, my spouse was one of the earliest study subjects for VNS Therapy for Depression (December 13, 1999). I am her long time support person and health care advocate/activist of 5 decades. The intent of the blog is not to promote any therapy, product or treatment but to continue sharing our experiences and knowledge as it relates to VNS. I endorse patient education in collaboration with a caring, knowledgeable and licensed health care professional while also encouraging hope and persistence.

Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

Most studies of transcranial magnetic stimulation (TMS) have focused on treatment of major depressive disorder, the indication for which this noninvasive device therapy has Food and Drug Administration approval. TMS also is under study for the treatment of headaches, as well as for improvement of the negative symptoms of schizophrenia.

Yet little work has been done on TMS for bipolar depression, even though a pressing need exists for new treatment options for this often highly disruptive mood disorder. Antidepressant medications are often ineffective or can trigger a switch to a manic or hypomanic episode, Dr. William S. Gilmer noted at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Dr. William Gilmer

He reported on 10 patients with bipolar II disorder and 4 who met criteria for bipolar disorder not otherwise specified. All had complicated nonpsychotic depression. All were refractory to and/or intolerant of multiple antidepressant agents during their current episode; indeed, the patients had previously been on a mean of 6.4 antidepressant drugs during this episode, which had already lasted more than 18 months in 9 of 14 cases. Four patients were previous nonresponders to ECT. None of the subjects had bipolar activation symptoms such as grandiosity, nocturnal alertness, or agitation at baseline, according to Dr. Gilmer, associate professor of clinical psychiatry and behavioral sciences at Northwestern University, Chicago.

After an extended period during which he attempted to optimize the participants’ medications, including reducing benzodiazepines and increasing mood-stabilizing drugs if necessary, all patients underwent high-frequency TMS at 10-Hz over the left dorsolateral prefrontal cortex 5 days per week according to the standard procedure using the NeuroStar device marketed by Neuronetics.

Nine of 14 patients achieved a clinically meaningful antidepressant response to TMS, as defined by at least a 50% reduction in scores on the Quick Inventory of Depressive Symptomatology (QIDS-16 SR) from an initial mean baseline of 18.9. A mean of 24.6 sessions was required. Four patients achieved and maintained remission, as defined by a QIDS-16 SR score below 6; this required a mean of 24.8 TMS sessions, followed by a taper phase.

Two of the four previous nonresponders to ECT achieved full remission on TMS, and a third had a significant response.

Although there were no study dropouts, seven patients experienced bipolar activation symptoms during TMS therapy that required drug therapy. Of note, four of five TMS nonresponders experienced clinically significant activation symptoms, compared with just three of nine TMS responders. Thus, the emergence of activation symptoms during TMS may turn out to be a predictor of poor outcome. This is a possibility warranting further study in controlled trials aimed at establishing optimal TMS treatment parameters in bipolar depression, the psychiatrist suggested.

Dr. Gilmer is on the speakers’ bureau for Neuronetics.

Vitals

Major finding: Nine of 14 patients with highly treatment-resistant bipolar depression achieved a clinically meaningful antidepressant response to transcranial magnetic stimulation, including 4 who reached and maintained remission. Two of the four in remission were prior nonresponders to ECT.

Data source: This observational study was a naturalistic case series with no control group. Patients had been unresponsive to and/or intolerant of a mean of 6.4 antidepressant medications during their current episode of bipolar depression, which had been ongoing for more than 18 months in nine cases.

Disclosures: Dr. Gilmer is on the speakers’ bureau for Neuronetics, which markets the transcranial magnetic stimulation device used in the investigation.

Published byStanford Medicine

An estimated 3 million adults and children in the United States suffer from epilepsy or seizures, and approximately 200,000 new cases occur annually, according to statistics from the Epilepsy Foundation. A portion of these patients can control their seizures with prescription drugs, but when medication fails, repeated seizures can seriously impair their daily life.

In the Stanford Program for Intractable Epilepsy, Josef Parvizi, MD, PhD, an associate professor of neurology and neurological sciences, works with epilepsy patients who are not responding to medication to determine if they are good candidates for surgical intervention. The procedure he performs involves removing a portion of the patient’s skull to provide access to the brain’s surface near the spot thought to be responsible for initiating the seizures. Electrode leads are placed next to the brain, with each electrode separately monitoring electrical activity there, allowing the function of the brain areas being considered for removal to be mapped and ensuring the surgery will be safe.

Below are Parvizi’s responses to a selection of questions on drug-resistant epilepsy and the procedure that were submitted using the hashtag #AskSUMed and the comments section on Scope. As a reminder, his answers are meant to offer medical information, not medical advice. They’re not meant to replace the evaluation and determination of your doctor, who will address your specific medical needs and can make a diagnosis and provide appropriate care.

Lisa K. asks: A recent study showed that surgery soon after the failure of two anti-epileptic drug trials offers the best chance for patients to prevent a lifetime of disability. How soon should patients seek a surgical intervention?

Yes, a study published in the Journal of the American Medical Association by Pete Engel, MD, PhD, and colleagues suggested that epilepsy surgery should NOT be considered as the last resort for intractable epilepsy. They selected patients who had been non-responsive to two consecutive antiepileptic medications for no more than two years before the trial. Some patients were treated with surgery and some continued taking their drugs without surgery. Patients were followed up for two years. Of those who received surgery, 73 percent experienced seizure freedom. By comparison, none of the patients who continued to take medications without surgery were seizure free. Moreover, quality of life was enhanced significantly in the surgery group. They could drive and spend time socializing with friends. How soon? Well, as soon as a patient fails two appropriately chosen and tolerated anti-epilepstic drug when used for an adequate period of time (greater than six months). If a patient has seizures and imaging studies show a clear lesion in the brain, then surgery should be considered immediately.

Matt asks: I have a 7 year-old girl with severe cognitive disabilities. She follows the Atkins for seizures diet; presented at 6 months, seizes once a week, duration 10 minutes unconscious, then 10-minute ‘tremors’. Would the procedure be considered ‘too late’ to affect her future learning? Also, her doctors believe the seizure focus to lie deep in her brain (not seen on MRI) – can this area be accessed if indeed this proves to be the location?

I am sorry to hear that your daughter is having so many seizures. It is important to monitor her seizures with video-EEG to characterize the type of events that she’s having. If these seizures are epileptic and focal, then yes, she should be considered for resection surgery, i.e., surgically remove the piece of the brain that is the focus of her seizures. If the seizures are multifocal, she could benefit from devices such as vagus nerve stimulator (VNS). One could also consider corpus callosotomy surgery if your daughter is having generalized seizures that cause her to fall and injure herself.

Jim Abrahams asks: I’ve read that since 1921 the ketogenic diet has improved over 50 percent of the thousands of children and adults with drug-resistant epilepsy and that as many as 20-30 percent become seizure and drug free. In addition to almost 100 years of published data, a randomized controlled study published in 2009 supported its efficacy in children. Could you comment?

A Cochrane analysis showed that the diet results in short to medium term benefits in seizure control – like the effect of any other medication. However, the long-term outcome of the diet is questionable. Many patients find the diet difficult to tolerate, and many drop-out from using this diet because of gastrointestinal side effects and dislike for the diet.

Nolan asks: I read that an experimental implantable device may benefit epilepsy patients who don’t respond to medication. What are the advantages of a surgical intervention compared to something like this type of implantable device?

Devices are only partially helpful. They reduce seizure frequency by ~35 percent (almost like a medication). Very rarely does a patient become seizure free. Removing the brain focus of seizures, on the other hand, can result in 100 percent seizure freedom.

@EpilepsyBlogger asks: Are there any new surgeries or implants being released in the future for patients who suffer with drug-resistant epilepsy?

Two new devices are waiting for approval in the U.S. One is made by NeuroPace and the other by NeuroSigma.

Source

Abstract

In 1997, the US Food and Drug Administration approved the use of intermittent stimulation of the left vagal nerve as adjunctive therapy for seizure control. Vagal nerve stimulation (VNS) has since been considered a safe and effective treatment for medically intractable seizures. The objective of this study is to present our experience with the surgical procedure and outcomes after VNS insertion in the first 100 consecutive patients treated at the Tel-Aviv "Sourasky" Medical Center (TASMC). All patients who underwent VNS device implantation by the authors at TASMC between 2005 and 2011 were studied. The collected data included age at onset of epilepsy, seizure type, duration of epilepsy, age at VNS device implantation, seizure reduction, surgical complications, and adverse effects of VNS over time. Fifty-three males and 47 females, age 21.2 ± 11.1 years, underwent VNS implantation. Indications for surgery were medically refractory epilepsy. The most common seizure type was focal (55 patients, 55 %). Seizure duration until implantation was 14.4 ± 9 years. Mean follow-up time after device insertion was 24.5 ± 22 months. Complications were encountered in 12 patients. The most common complication was local infection (6 patients, 6 %). Six devices were removed-four due to infection and two due to loss of clinical effect. Currently, 63 patients remain in active long-term follow-up; of these, 35 patients have >50 % reduction in frequency of attacks.VNS is a well-tolerated and effective therapeutic alternative in the management of medically refractory epilepsy. The surgical procedure is safe and has a low complication rate.

Efficacy of vagus nerve stimulation as a treatment for medically intractable epilepsy in brain tumor patients. A case-controlled study using the VNS therapy Patient Outcome Registry.

Source

Abstract

PURPOSE:

Vagus nerve stimulation (VNS) therapy is a procedure to control seizure frequency in patients with medically intractable epilepsy. However, there is no data on efficacy in the subset of these patients with brain tumors. The purpose of this study is to evaluate the efficacy of VNS therapy in patients with brain tumor-associated medically intractable epilepsy.

METHODS:

Data from the VNS therapy Patient Outcome Registry, maintained by the manufacturer of the device, Cyberonics Inc. (Houston, TX, USA), was queried to characterize the response of patients in whom a brain tumor was listed as the etiology of epilepsy. A case-control analysis was implemented and patient outcome was measured by Engel classification, median seizure response and responder rate (≥50% seizure reduction) using t-tests and chi-squared tests.

RESULTS:

In 107 patients with an epilepsy etiology related to a brain tumor, seizure reduction was 45% at 3 months and 79% at 24 months with a responder rate of 48% at 3 months and 79% at 24 months. There was no statistical difference in seizure reduction compared with 326 case-control patients from the registry without brain tumors. There was no significant difference in anti-epileptic drug (AED) usage from baseline to 24 months post implant in either group.

CONCLUSIONS:

VNS therapy is equally effective in patients who suffer seizures secondary to brain tumors as in patients without history of a brain tumor. VNS therapy is a viable treatment option for patients with brain tumor associated medically intractable epilepsy, assuming cytoreductive and other adjuvant therapies have been fully explored.

Late-Onset Advanced Heart Block Due to Vagal Nerve Stimulation.

Source

Department of Internal Medicine, Division of Cardiology. University of New Mexico, Albuquerque, NM.

Abstract

Vagal nerve stimulation (VNS) is widely accepted as an effective and safe therapy for refractory seizure disorders. Significant cardiac complications, such as complete heart block or symptomatic bradycardia, are extremely rare. We present a case report of a 40-year-old man with drug-resistant epilepsy, treated with VNS, who developed the late-onset (12 months after implant), stimulation-related, symptomatic advanced heart block that was initially misinterpreted for a new type of seizure. The patient was otherwise free from other stimulation-related side effects. To our knowledge, this is the first case report of late-onset advanced heart block due to VNS.

Source

Seton Hall University, Edison, NJ, USA. sbhat2012@yahoo.com

Abstract

Vagal nerve stimulation (VNS) has been reported to adversely impact breathing in sleep. While continuous positive airway pressure is often employed to treat these patients, little data exist on the effects of adjusting various settings on VNS-induced sleep-disordered breathing. We describe a patient in whom increasing off-time caused resolution of VNS-induced arterial oxygen desaturations in sleep, which we believe is a novel observation.

An open-label, multicenter, pilot study suggests that noninvasive vagus nerve stimulation (nVNS) can be effective for acute treatment of migraine.

An analysis of 25 women and two men treated with nVNS for migraine with or without aura showed that patients were pain-free two hours after treatment in 38% of mild migraine attacks and 22% of moderate or severe attacks. Twelve of the patients had adverse events, but all were mild or moderate, according to a presentation of the results by Peter Goadsby, MD, PhD, at the American Academy of Neurology’s 2013 annual meeting, held recently in San Diego.

“Noninvasive or transcutaneous VNS is well tolerated and seems to be effective in acute migraine,” concluded Dr. Goadsby, professor of neurology at the University of California, San Francisco. “This points to the importance of getting on with controlled trials—and indeed there are two studies each in Europe and the U.S. under way already.”

Ana Recober, MD, assistant professor of neurology at the University of Iowa, University Heights, chaired the session at which Dr. Goadsby presented the data. She praised the results as being “exciting” and warranting “follow-up with a larger randomized, double-blinded, sham-controlled clinical trial.”

“The headache community is looking for new, innovative acute-migraine treatments, and non-medicinal therapies with minimal side effects are very attractive,” said Todd Rozen, MD, director, Geisinger Headache Center, Geisinger Health System, Wilkes-Barre, Pa. “The two-hour data for pain freedom and pain relief in the study are promising, but the investigators didn’t indicate whether the pain returns within 24 hours, or even within four hours for that matter. Also, no data were presented on what happened to migrainous-associated symptoms—such as nausea and vomiting—with treatment.”

He agreed that results from the controlled trials would be useful. Dr. Goadsby said data on migraine symptoms up to 24 hours post-treatment would be included in a paper that is being prepared for submission to a medical journal.

The pilot study was paid for by ElectroCore, which makes the gammaCore device that was used in the study. The goal was to build on several published case series on use of nVNS that showed it relieved some patients’ migraine symptoms (see, e.g., Cephalalgia 2005;25:82-86).

The participants had a median age of 39 years. Each was treated with nVNS for four consecutive migraine attacks, either with immediate treatment for moderate or severe attacks, or after 20 minutes of mild pain. Each treatment consisted of one 90-second dose followed by another dose 15 minutes later.

The initial study population included 30 individuals but three did not have any attacks treated; thus, the intent-to-treat group comprised 27 subjects. In that group, there were 84 attacks, 55 of which were moderate or severe. In 10 of the mild attacks (38%) and in 12 of the moderate or severe attacks (22%), the patients were pain-free after two hours.

Three patients experienced neck twitching at the location of the treatment; one had neck redness; and another reported a raspy voice. The adverse effects all were only present during the stimulation time and resolved spontaneously.

—Rosemary Frei, MSc
Dr. Goadsby is a consultant with ElectroCore. Drs. Recober and Rozen did not disclose any relevant conflicts of interest.

Parkinson's disease patient Andrew Johnson recorded a video of what happens when he turns off his deep brain stimulation (DBS) pacemaker, demonstrating the dramatic relief his implant offers from motor symptoms.

By Ashik Siddique | Jun 21, 2013 03:50 PM EDT Since his diagnosis with Parkinson's disease in 2009, when he was 35 years old, New Zealand blogger Andrew Johnson had suffered progressively more debilitating motor symptoms like tremors and impaired balance.

His motor coordination became so impaired that last year, he opted for a cutting-edge surgical treatment that is becoming increasingly common among Parkinson's disease patients: deep brain stimulation (DBS).

This groundbreaking technique involves the implantation of a pacemaker in the motor region of the brain, which is programmed to deliver steady electrical pulses to surrounding tissues in order to stop tremors.

Johnson underwent one implant surgery in November 2012, as well as a follow-up operation to insert a second probe in February 2013. After four months of living with the pacemaker brain implants, he said on Youtube that deep brain stimulation "has been hugely beneficial to his quality of life."

He has chronicled his life with Parkinson's disease on his blog YoungAndShaky in the past year, and is now drawing attention online for discussing his experience on the social media websites Youtube and Reddit.

In a remarkable video posted to Youtube last week, the now 39-year-old Johnson displays what happens when he turns off the remote-control-operated pacemakers.

The effect is dramatic. When the pacemaker runs normally, Johnson can keep his arms completely still while extended, then rapidly wiggle his fingers to demonstrate his motor reflexes.

After pressing the "off" button on the pacemaker remote control, his tremors begin almost instantaneously. His hands uncontrollably shake, his voice begins to waver, and his neck twitches with muscle dystonia.

Over the course of only one minute, the tremors increase in intensity until Johnson is close to dropping the remote control. When he finally manages to press the button, the tremors stop automatically.

Last month, UCLA surgeons made waves when they live-streamed videos and photos of the DBS brain surgery of 39-year-old Brad Carter on the social media platforms Vine and Instagram, culminating in the Parkinson's disease patient playing guitar while he was still under the knife in order to test the pacemaker implant's effectiveness in calming his tremors.

Johnson acknowledged on Reddit that the brain pacemakers aren't perfect — airport security scanners can sometimes turn them off, so he needs to warn officers about his condition so they can pat him down instead.

He actually made the video in preparation for an upcoming plane flight, he wrote in a blog post — he had never before turned off the pacemaker, and wanted to record what happened.

Johnson clarified that DBS pacemakers do not cure Parkinson's disease, but avoid some of the undesirable effects of drugs like L-Dopa — "it doesn't stop or slow the disease it just replaces the effects of the medications I take (which have long term evil effects)."

The long-term effects of deep brain stimulation are unclear, the immediate quality of life improvement makes Johnson willing to take the risk of future drawbacks, since it allows him to enjoy time with his wife and two children in their Auckland home.

"For me, my kids are 3 and 6, so the risk of dying/stroke etc were outweighed by the fact that my kids deserved a dad for as long as they can and my wife deserved her husband back so this has given them that," he explained on Reddit. "So long may it last I say."

Thursday, June 20, 2013

Brain Scans Predict Best Course of Treatment for Patients with Depression

June 13, 2013

Helen S. Mayberg, M.D.

Brain & Behavior Research FoundationScientific CouncilMember and three-time NARSAD Grantee Helen S. Mayberg, M.D., was principal investigator for a study that showed that specific patterns of brain activity can help indicate how a depressed person will respond to treatment with medication or psychotherapy. The study results, published in JAMA Psychiatry online on June 12, 2013, offer a first step towards personalized medicine treatment decisions for major depression. The findings are especially important because at present less than half of patients experience remission with the treatment initially selected.

Dr. Mayberg has long been committed to improving the lives of patients with depression and other mental illnesses. She pioneered the use of positron emission tomography (PET) to investigate brain changes in depressed patients with her first NARSAD Young Investigator Grant 20 years ago. Since that time, with the support of two further NARSAD Grants―and countless other grants―she successfully identified a key locus of pathology in depression (the subcallosal cingulate or Brodmann Area 25) and piloted the use of deep brain stimulation (DBS) to target this “Area 25” to treat patients with resistant depression.

Her new study sought to identify a biomarker that could predict which type of treatment a patient would benefit from based on the individual’s brain activity. The research team measured brain glucose metabolism (a critical brain function) in two groups of participants during a span of 12 weeks. After having a PET scan, half of the participants were given an antidepressant medication and the other half were given cognitive behavior therapy (CBT).The researchers found that less activity in the brain’s anterior insula indicated response to CBT, and more activity indicated response to medication.

"To be ill with depression any longer than necessary can be perilous," says Dr. Mayberg, Dorothy C. Fuqua Chair in Psychiatric Imaging and Therapeutics, Emory University School of Medicine. "This is a serious illness and the prolonged suffering resulting from an ineffective treatment can have serious medical, personal and social consequences. Our goal is not just to get patients well, but to get them well as fast as possible, using the treatment that is best for each individual."

"These data suggest that if you treat based on a patient's brain type, you increase the chance of getting them into remission," says Dr. Mayberg. More study is needed to confirm how this approach may be used to deliver treatments more effectively and how to apply it to different types of depression.

Source

Abstract

In 1997, the US Food and Drug Administration approved the use of intermittent stimulation of the left vagal nerve as adjunctive therapy for seizure control. Vagal nerve stimulation (VNS) has since been considered a safe and effective treatment for medically intractable seizures. The objective of this study is to present our experience with the surgical procedure and outcomes after VNS insertion in the first 100 consecutive patients treated at the Tel-Aviv "Sourasky" Medical Center (TASMC). All patients who underwent VNS device implantation by the authors at TASMC between 2005 and 2011 were studied. The collected data included age at onset of epilepsy, seizure type, duration of epilepsy, age at VNS device implantation, seizure reduction, surgical complications, and adverse effects of VNS over time. Fifty-three males and 47 females, age 21.2 ± 11.1 years, underwent VNS implantation. Indications for surgery were medically refractory epilepsy. The most common seizure type was focal (55 patients, 55 %). Seizure duration until implantation was 14.4 ± 9 years. Mean follow-up time after device insertion was 24.5 ± 22 months. Complications were encountered in 12 patients. The most common complication was local infection (6 patients, 6 %). Six devices were removed-four due to infection and two due to loss of clinical effect. Currently, 63 patients remain in active long-term follow-up; of these, 35 patients have >50 % reduction in frequency of attacks.VNS is a well-tolerated and effective therapeutic alternative in the management of medically refractory epilepsy. The surgical procedure is safe and has a low complication rate.

Efficacy of vagus nerve stimulation as a treatment for medically intractable epilepsy in brain tumor patients. A case-controlled study using the VNS therapy Patient Outcome Registry.

Source

Abstract

PURPOSE:

Vagus nerve stimulation (VNS) therapy is a procedure to control seizure frequency in patients with medically intractable epilepsy. However, there is no data on efficacy in the subset of these patients with brain tumors. The purpose of this study is to evaluate the efficacy of VNS therapy in patients with brain tumor-associated medically intractable epilepsy.

METHODS:

Data from the VNS therapy Patient Outcome Registry, maintained by the manufacturer of the device, Cyberonics Inc. (Houston, TX, USA), was queried to characterize the response of patients in whom a brain tumor was listed as the etiology of epilepsy. A case-control analysis was implemented and patient outcome was measured by Engel classification, median seizure response and responder rate (≥50% seizure reduction) using t-tests and chi-squared tests.

RESULTS:

In 107 patients with an epilepsy etiology related to a brain tumor, seizure reduction was 45% at 3 months and 79% at 24 months with a responder rate of 48% at 3 months and 79% at 24 months. There was no statistical difference in seizure reduction compared with 326 case-control patients from the registry without brain tumors. There was no significant difference in anti-epileptic drug (AED) usage from baseline to 24 months post implant in either group.

John Moden of Swartz receives Transcranial Magnetic Stimulation therapy Tuesday from TMS coordinator Robin Walker at the office of Dr. Calvin Walker in Monroe. TMS is used to treat patients who suffer from depression and aren't responding to medication. / Dacia Idom/The News-Star

After trying a number of different medications, John Moden said nothing seemed to be effectively

treating his depression.

Moden, of Swartz, said he would feel anxious and stressed all the time, making it hard for him to sleep at night and to fully appreciate life.

That was until he tried Transcranial Magnetic Stimulation therapy, which uses highly focused magnetic pulses to stimulate key neurons in the brain.

“Now I’m more relaxed, and once you can relax, you see the need to smell the flowers,” he said. “You can enjoy various things you wouldn’t have before.”

With TMS, an electromagnetic coil is placed against a person’s scalp near their forehead. The electromagnet creates electric currents that stimulate the part of the brain involved in mood control and depression. TMS was approved by the Food and Drug administration in 2008.

Moden, who is in remission, underwent 30 TMS treatment sessions at the office of Dr. Calvin Walker, a psychiatrist in Monroe.

Walker said he is the only doctor in northeastern Louisiana using a TMS machine, which he has had for less than two years and has used to treat 12 patients.

He said 11 of the 12 patients who underwent TMS went into complete remission from their depression. The other patient relapsed and had to continue with the treatments, he said.

“We’re very pleased with the response we’ve had with the patients we’ve had the opportunity to help,” Walker said.

TMS is meant to be used on patients with unipolar depression for whom medications have not worked, Walker said.

“Medicine is still important. We don’t do the TMS all by itself. We try to maybe cut down the medicine while they undergo the treatment,” he said. “If you use TMS with the medicine, in my opinion, it doubles the chance that they’ll get better.”

Patients will undergo 30 TMS treatment sessions, with each session lasting about 40 minutes. The treatments start out five times a week and then taper off to about twice a week after the first few weeks, Walker said.

He said patients can start seeing results after the first two to three weeks.

“I think it’s wonderful. We’ve had very good results,” he said. “We’re hoping we can help more people.”

John Moden’s wife, Margie Moden, said she has seen remarkable improvement in her husband’s health since undergoing TMS.

“He enjoys life more,” she said. “It was a very good decision. You can’t put a price tag on your quality of life.”

Suzanne and Raymond Chevrette have been married for more than 30 years.

During that time, Raymond will tell you his wife has had seizures weekly, some of them lasting 20 minutes or longer. She doesn't remember them but she does know one thing.

"They got really bad," Suzanne said, to the point where she was "out of it."

"She was having three or so a week, and she's tried a couple medications and it really wasn't stopping them," said Dr. Charles Kanaly of Memorial Hospital of Rhode Island.

When Suzanne was referred to Kanaly, he suggested VNS therapy. It's not new. This device-based treatment was FDA approved to treat seizures in 1997, but in Kanaly's opinion it's underutilized for uncontrolled seizures.

"There's a little pacemaker battery and then (a) little wire, and basically we wrap these coils around the nerve so the nerve is running down … in the neck," Kanaly said.

The battery is placed in an incision in the crease under the clavicle.

The procedure is done on an outpatient basis and takes about 45 minutes.

"It puts a little electrical stimulation over the vagus nerve that runs down through the neck into the main organs in the body, and that sends a signal up in to the brain that helps decrease seizure frequency," Kanaly said.

Suzanne said she hasn't had a seizure since the device was implanted on March 5.

"Certainly can't promise that with every person who gets these, but it's a great outcome, definitely," Kanaly said.

VNS therapy is indicated for people with epilepsy who don't benefit from or can't tolerate anti-seizure medications. In addition to treating seizures, the FDA has also approved it, more recently, to treat people with severe depression.

Monday, June 10, 2013

Together, Butler Hospital and Rhode Island Hospital are participating in The ADvance Study, a clinical trial investigating the use of deep brain stimulation (DBS) as a treatment for patients with Alzheimer's disease. The collaborative study between the two hospitals is part of a multisite clinical trial investigating the safety and efficacy of DBS in slowing the loss of memory and cognition in patients with Alzheimer's disease, a disease which currently afflicts more than 5 million people in the US and for which there is no cure.

A device currently used to treat other brain-related conditions, DBS is often described as a 'pacemaker for the brain,' as it uses an implanted device to electronically stimulate the brain. In the ADvance Study, a pacemaker-like device is implanted beneath the skin in the patient's chest to deliver electrical pulses directly to the fornix- a part of the brain that plays a central role in memory. DBS is currently FDA approved to treat Parkinson's disease, Tourette's syndrome and resistant Obsessive Compulsive Disorder.

"Alzheimer's researchers from around the world, including those at Butler and Rhode Island Hospital, are committed to developing safe and effective treatments for Alzheimer's disease," said Stephen Salloway, MD, principal investigator for the study and director of the Memory and Aging Program at Butler Hospital. "DBS has helped transform the treatment of Parkinson's disease and we hope that stimulation of memory circuits can have a similar benefit in treating Alzheimer's disease." Salloway notes that the approach in this study differs from medications and vaccines that are being investigated for Alzheimer's disease. DBS uses a device that has already been safety-checked and FDA approved for treating other conditions and has been shown to be safe in early studies with Alzheimer's patients.
This clinical trial stems from a preliminary DBS study in six patients with Alzheimer's disease in Canada. That study found that patients with mild forms of the disease showed sustained increases in glucose metabolism, an indicator of neuronal activity, over a 13-month period. Most patients with Alzheimer's disease show decreases in glucose metabolism over the same time period.

In the double-blind clinical trial being conducted at Butler and Rhode Island Hospital, all participants will have the device implanted. Half of the participants will have the device activated in the first year, and all participants will receive active stimulation in the second year of the study. Following an initial evaluation at Butler, participants will have the device implanted at Rhode Island Hospital under the direction of Garth Rees Cosgrove, MD, chief of neurosurgery at Rhode Island Hospital, Chairman of the Department of Neurosurgery at Warren Alpert Medical School of Brown University, and Director of the Norman Prince Neuroscience Institute at Rhode Island Hospital.

"The results of the preliminary trial are very encouraging," said Dr. Cosgrove. "We have seen tremendous success in using deep brain stimulation on many of our patients with other neurological illnesses such as Parkinson's disease, and it has truly been a life-changing treatment. If we can achieve a similar response with our Alzheimer's patients then we will have the opportunity to improve millions of lives."

After the device is implanted, participants will visit Butler to have the device programmed by Victoria Chang, MD, a neurologist with expertise in DBS programming. Researchers at Butler will monitor safety outcomes and changes in memory, cognition and daily functioning with brain scans performed at Rhode Island Hospital. "This study is an example of a true collaborative effort between our two hospitals and health care systems to make progress against a devastating illness," said Dr. Salloway.

Saturday, June 8, 2013

One of the KOL's (Key Opinion Leaders) who I have intermittently corresponded with over the years replied to one of my recent emails which was directed to Cyberonics CEO Dan Moore and a number of other KOL's.

What is important although I have been requested to not publicly share the response was the fact the doctor is in agreement with my petition and feels strongly these volunteer medical study subjects should be cared for by Cyberonics and that they should honor their commitment.

Aside from the fact that he was in agreement with my position; even more importantly he broke that invisible code of silence which often perturbs me. He took the high road toward ethics and rightful morals in the interests of the patient in my opinion.

We need practitioners honoring their professional oath and speaking out especially when they truly know right from wrong and where they put their patients wellbeing first and not $$$$$$ signs.

I’d like to congratulate you on your outstanding and
record breaking profitable quarter. There is no doubt I would believe in
anyone’s mind that your stewardship has brought Cyberonics from the brink of
disaster to a remarkable financial recovery and profitability.

At the same time I have been patient as I awaited CMS
response to your most recent request for depression approval. CMS having
declined this recent request I cannot wait any longer. I have just
embarked upon a campaign covered in the petition I’ve pasted below. I am
making my best efforts to put my campaign in the front of as many governmental
officials, President of the United States, Senators, Congress people, FDA, CMS
and other governmental agencies, news media including newspapers, magazines and
television, the APA and various medical associations, as well as the general
public for support to get you and your company to honor the previous public
commitments of the former CEO and to standup and be morally responsible and
adherent to the desperate needs of these former study subjects
hung-out-to-dry.

Please also understand I still remain very supportive
of VNS Therapy for Depression as a viable treatment option to be considered by
patients in collaboration with one’s attending healthcare practitioner.

I strongly feel at this point in time although the FDA
had approved the therapy for depression the only way the therapy will overcome
CMS denial is to re-institute a new properly prepared double-blind study and
not one following a drug protocol. A study more suited for a
neuro-modulation device requiring considerably more time to demonstrate
efficacy. But then again, I’m sure you already know that and based upon
Dr. Conway’s demonstrated favorable results you would have someone very capable
of structuring the new study and protocol and someone already compassionate to
the plight of the current study subjects. Although, I cannot wait any
longer.

Joyce has done remarkably well over these past 13
years in terms of no depression. Joyce was last re-implanted in January
2005. This coming January will be 8 years of service on her 2nd
and current prosthesis, if it lasts that long, You have put us and others
former study subjects in a very precarious, tenuous and extremely stressful
situation.

I have inquired and been told I cannot undertake any
legal action at this time against Cyberonics based upon a future event.
That is until Joyce’s battery is depleted and our insurance carrier (United
Healthcare) and your company formally denies covering Joyce’s pulse generator
replacement surgery.

Please understand my position and rest assured that
unless something can be favorable accomplished for these former study subjects
and Joyce as well whereby you reconsider your position before Joyce’s need for
replacement that I shall continue my campaign to make an all-out effort to make
Cyberonics both legally and financially responsible for breaking and reneging
on its previous publicly stated commitments (“Lifetime Reimbursement Guarantee
for All TRD IDE Study Patients…”) while also making sure the news media and
general public stays informed as best I can.

As always I wish you continued success and wellness
for you and yours.

Sincerely,

Herb

Cc: Benedict Carey, New York Times

Barnaby J. Feder, New
York Times

P.S. Doc Mickey and Doc Steve I would hope that you
take this matter seriously under consideration by sharing our petition and
campaign on your respective blog sites and encouraging your respective
readership to sign on with us.

Caution: Do not
volunteer for any medical research until you read this petition.

VNS THERAPY FOR DEPRESSION (VAGUS NERVE STIMULATION)

The Petition:
The purpose of this petition is quite simple and straight forward, that is to
obtain health insurance coverage for a group of volunteer medical study
subjects for an FDA (Food and Drug Administration) approved therapy and to warn
all medical volunteer study subjects to obtain in writing who is responsible
for their medical care if CMS (Centers for Medicare and Medicaid Services)
and/or one’s insurance company denies coverage. FDA approval does not mean or
insure health insurance coverage.

Background:
On or about 1997 Cyberonics, Inc. received FDA approval for VNS Therapy for
Epilepsy. On or about 1998 Cyberonics additionally got the go ahead to
institute an open pilot study (D-01) for the same VNS Therapy for Depression.
The D-01 was instituted as a result of Epilepsy studies and patients not only
reporting decreases in number and severity of their seizure activity but also
diminishing depression episodes.

Through the assistance and caring of my spouse’s then attending psychiatrist,
Dr. Paul Goodnick, Joyce was enrolled in the D-01 open study as study subject
#46 at MUSC (Medical University of South Carolina) under the directorship of
Dr. Mark George and Dr. Ziad Nahas. She was implanted with the device on
December 13, 1999.

In our desperation at the time and after some 36 years of Joyce’s continuing
severe depressive episodes and suicidal attempts and failed therapy trials as
well as numerous ineffective medications and refractory treatments, she signed
the papers for this newest neuro-modulation study.

We carefully noted that death was a possible outcome. We also noted once FDA
approved, Cyberonics would no longer be responsible for her medical care.

What we didn’t know or realize at the time of signing nor did any of the study
volunteers and worse yet the fact that all the other affiliated parties and
medical professionals didn’t take into consideration when structuring any of
these depression studies that with FDA approval it ended Cyberonics
responsibility for medical care but it did not insure Medicare/Medicaid and/or
health insurance coverage for the study subjects. Nor did anyone know despite FDA
approval that CMS denying coverage for this medical device (historically the
first time such an event took place) left these volunteer patients in a
Catch-22 with an implanted medical device and some with paid health insurance
but still denied coverage for this particular therapy.

VNS Therapy, VNS depression studies, Cyberonics, the former CEO Robert P.
(“Skip”) Cummins and the FDA have all been steeped in controversy and maligned
as well. Yet and at the time, when I brought this loophole to the attention of
Mr. Cummins he assured me “not to worry.”

Mr. Cummins honored his words and to his credit, took action and made a
responsible and morally correct pronouncement. He acted and assured the
depression study subjects would have health coverage for the VNS Therapy if
their own health insurance and/or Medicare/Medicaid carriers denied to cover
the therapy by publicly announcing on January 18, 2006:

“Lifetime Reimbursement Guarantee for All TRD IDE Study Patients and $15
Million TRD Indigent Care Program…Cyberonics has taken the unprecedented steps
with its lifetime reimbursement guarantee for study patients and its $15
million TRD Indigent Access Program, to ensure that study patients and indigent
Americans with TRD have fully informed access to VNS Therapy.”

Similar information was also entered into the Cyberonics corporate 8-K SEC
filings.

Mr. Skip Cummins is no longer with Cyberonics and the current management has
reneged upon their oral and published contract, commitments and statements. The
company has refused to pay for the servicing, care and replacement of their
implantable devices for those volunteer study subjects (patients) wanting to
continue the therapy.

A number of these volunteers, who were devastatingly ill, are benefiting
long-term and living reasonable quality of lives as a result of VNS Therapy.
These patients are being denied health insurance coverage by their own paid for
carriers as well as Medicare/Medicaid despite the fact the therapy works for
them and was FDA approved.

Adding to the illogic of this conundrum is the fact the very same therapy is
covered by Medicare/Medicaid and health insurance carriers for epilepsy and
that some 200 leading psychiatric professionals had commented during the
write-in period to CMS that the therapy should be approved for coverage based
upon their personal patient treatment experiences and that conventional
therapies are ineffective for this unique population of seriously ill patients.

In the infinite “lack” of wisdom on the part of our government’s convoluted
working agencies to protect us the FDA, CMS as well as the sponsor and the oath
taken by all the medical researchers (to do no harm) no one thought to ask or
provide for health care and replacement coverage for these medical volunteers. Thereby
leaving these study subjects (my spouse included) with a costly implanted
medical device and therapy that no study subject rightfully or morally should
be paying for out-of-pocket especially since we have health insurance.

CMS in their denial of coverage should have rightfully grandfathered in the
existing study subjects. They did not.

One last and most important point; Joyce and I still remain advocates for VNS
Therapy for Depression as a potentially viable treatment option to be
considered by a reasonably informed patient.

As a result of this therapy my spouse has been depression free approaching 14
years. We no longer discuss depression. She takes no antidepressants. Our major
concern is to continue maintaining her past 14 year wellness utilizing the same
VNS Therapy and to have our paid for health insurance carrier, Cyberonics
and/or any other responsible party honor their commitments to cover Joyce’s
medical expenses and that of the other study subjects as they do for epilepsy.

At the same time to once again caution and make aware to other volunteer
medical study subjects in any other kind of study to not get caught up in a
very stressful similar and costly situation and negligent oversight.

Conclusion:
Please sign and join this petition to correct this medical injustice:

I am requesting The United States President, Senate, Congress, CMS, state and
local governmental officials, Health Insurance Industry, Cyberonics and all
medical professionals especially those having anything to do with VNS Therapy
for Depression to do the responsible and morally correct thing by exerting
pressure upon any of the responsible parties to correct this oversight and
injustice by helping these volunteer study subjects (patients) to obtain
medical coverage and to insure future medical study volunteers are not faced
with a similar predicament.

Thank you all for your consideration in reading this petition and joining in to
obtain health care for all medical research study volunteers.

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About Me

I'm a very, very long-time support person and mental health advocate/activist for my spouse Joyce as well as to others. I'm also a retired business executive and former Board Member, President and facilitator of a local chapter of DBSA as well as a Florida State appointment as a Guardian Advocate. I do not endorse, promote or advertise for any therapy, product or company. I do share our personal experiences, my research and knowledge in the hope it might benefit someone or do I give advice as to what one should or shouldn't do. I extend my best wishes for wellness to one and all and all the good you’d wish for yourselves.